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Analytical R&D Manager

Location : Philadelphia PA US 19154
Job Type : Direct
Reference Code : 18676-AB
Compensation : 100000.00 - 120000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for an Analytical R&D Manager to lead all analytical development for expanding Philadelphia area manufacturer of generic and branded pharmaceuticals. Specific responsibilities include:

  • Oversee all method development, validation and documentation activities for ANDAs and product launches.    

  • Investigate and troubleshoot analytical issues.

  • Manage equipment calibration and laboratory maintenance to comply with CGMPs, FDA and OSHA.

  • Generate SOPs, technical documents, and new instrument Qualification program.

  • Design of experiments including early stage product development Dissolution / Drug Release procedures.

  • Complete US and EU regulatory documentation to ensure regulatory agency standards are met.

Required Qualifications :

  • BS Chemistry (advance degree preferred).

  • Minimum 10 years pharmaceutical laboratory experience including at least 3 years in a supervisory role.

  • Proficient with validation of analytical. instrumentation such as GC, LC-MS, UPLC, HPLC, Titration, Dissolution, UV-VIS, and IR.

  • Knowledge of Analytical Quality by Design and Design of Experiments.

  • Able to lead root cause analysis and implement corrective actions in a timely manner.

  • Experience implementing statistical techniques.

  • Proficient in drug development and manufacturing regulatory requirements.

  • Excellent project and time management skills, computer literacy, verbal and technical writing communication skills, presentation skills, interpersonal skills, leadership and teambuilding skills, and problem solving skills.

Contact: Allan Berman

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